Glossary Term
Market Clearance
Definition
Market clearance refers to the authorization granted by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), for a medical device to be legally marketed and distributed. Unlike market approval, which often requires rigorous clinical evidence for high-risk devices, market clearance typically applies to devices demonstrated to be substantially equivalent to a legally marketed predicate device.
Relevance to the MedTech Industry
Market clearance allows medical device manufacturers to bring low- to moderate-risk devices to market efficiently. It ensures that these devices meet basic safety and performance standards without requiring the extensive testing and documentation necessary for high-risk devices.
Additional Information & Related Terms
Key Steps to Achieving Market Clearance
Device Classification
Determine the device class (Class I, II, or III) and the applicable regulatory pathway.
Most devices requiring market clearance are Class II.
Identify a Predicate Device
Choose a legally marketed device with similar intended use and technical characteristics.
Demonstrate Substantial Equivalence
Provide evidence that the device is as safe and effective as the predicate device.
Prepare and Submit Documentation
Compile a premarket notification (510(k) submission) that includes device description, testing data, and substantial equivalence comparison.
Regulatory Review
Respond to any questions or requests for additional information from the regulatory authority.
Obtain Clearance
Receive confirmation from the regulatory body, such as an FDA letter confirming that the device can be marketed.
Related Terms
510(k): The regulatory process for obtaining market clearance from the FDA.
Substantial Equivalence: Demonstrating that a device is as safe and effective as a predicate device.
Good Manufacturing Practices (GMP): Standards for ensuring consistent production quality.
CE Marking: European certification allowing a device to be marketed in the EU, differing from market clearance.
Post-Market Surveillance (PMS): Ongoing monitoring required to ensure continued compliance after clearance.